Assessment of a clinical outcome can be made through report by a clinician, a patient, a non-clinician observer or through a performance-based assessment. There are four types of COAs.

• clinician-reported outcome
• observer-reported outcome
• patient-reported outcome
• performance outcome

Relevant links:

FDA/Center for Drug Evaluation and Research Guidance for Industry and FDA Staff: Qualification Process for Drug Development Tools

FDA/Center for Drug Evaluation and Research Clinical Outcome Assessment Qualification Program Webpage

FDA/Center for Drug Evaluation and Research Drug Development Tools (DDT) Qualification Programs Webpage

FDA/Center for Devices and Radiological Health Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff: Medical Device Development Tools

FDA/Center for Devices and Radiological Health Medical Device Development Tools (MDDT) Webpage